Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury.
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 29, 2011 | ||||||||
| Last Updated Date | September 6, 2012 | ||||||||
| Start Date ICMJE | October 2009 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Reduced Affective Lability [ Time Frame: Study weeks 1-10 ] [ Designated as safety issue: No ] The primary analysis addresses our primary hypothesis that treatment with divalproex sodium will lessen affective lability significantly (p<0.05) as compared to placebo. We will characterize affective lability using discrete variables of presence or extent of symptoms yielded by the Neurobehavioral Rating Scale-Revised (Levin et al., 1990) as well as eight target items from the Agitated Behavior Scale (Bogner et al., 2000). Average intensity and duration of affective lability will be compared between groups. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01326663 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Reduced Alcohol Use [ Time Frame: Study weeks 1-10 ] [ Designated as safety issue: No ] The secondary analysis first addresses our secondary hypothesis that treatment with divalproex sodium will lessen quantity and frequency of ethanol use significantly (p<0.05) as compared to placebo in a sample of TBI subjects. We will characterize drinking using the Time Line Follow-Back for Drugs and Alcohol method, developed by Sobell et al (Sobell et al., 1979). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury. | ||||||||
| Official Title ICMJE | A Double Blind Trial Of Divalproex Sodium For Affective Lability And Alcohol Use Following Traumatic Brain Injury | ||||||||
| Brief Summary | Despite the body's natural healing during the first year after a head injury, many veterans who have suffered even mild brain injuries find themselves easily upset or fearful as they go about their daily lives. While these reactions to the world around them were easily managed before the head injury, they now occur with little or no interruption and are exceedingly difficult to manage. Such reactions include a sense of always being upset or fearful that often makes it difficult to get along with family members, friends, coworkers, and employers. This may lead to broken marriages, unemployment, and even homelessness. Some people with head injuries try to manage their unmanageable moods by drinking alcohol because it can create a sense of calm. However, alcohol's actions are short in duration. Most find that they have to drink more and more for a similar calming effect, and they soon become dependent on alcohol. This makes working and being part of their families even more difficult. To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood problems in people without head injury. We gave valproate to head injured persons with mood problems in a "non-blinded" study where both the doctor and the patient knew that the medicine was valproate and both were optimistic that it would work. In a small sample of eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or drank much less than before. However, this might have been because both the doctor and patient were hopeful that the medication would make the patient feel better or because the medicine actually worked. The only way to know for sure if the medicine works is to perform a study in which people receive either valproate or a sugar pill while neither they nor their doctor know which one they are taking. This is called a double blind study, as proposed here, and will involve nearly three times as many head injured persons as the first study. If it is successful, this study will show that valproate treatment helps head injured people manage their moods and allows them to return to families, friends, and work. It will also show that they drink alcohol less or not at all, improving their health even further. Then doctors will know that they can use this medicine for large numbers of people who suffer from head injury and help them to lead normal lives. If the outcome of the study shows that the medicine works well, doctors can then use this medicine to treat people with head injury immediately after the study results are published. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Intervention ICMJE | Drug: Medication Trial | ||||||||
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01326663 | ||||||||
| Other Study ID Numbers ICMJE | PT075168 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Paul Saenger, Denver Research Institute | ||||||||
| Study Sponsor ICMJE | Paul Saenger | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Denver Research Institute | ||||||||
| Verification Date | September 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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